Uveitis
Conditions
Keywords
Uveitis, Optical Coherence Tomography
Brief summary
Optical Coherence Tomography (OCT) is routinely used in ophthalmic clinical practice. It uses infrared light to image patient's eyes. Some patients, such as those with an inflammatory disease called uveitis or those who have just undergone cataract surgery, have intraocular inflammation. This intraocular inflammation commonly manifests as cells that can be seen on routine microscopic clinical examination. However, the only currently available method to quantify this intraocular inflammation is by manually counting on the microscopic clinical examination. The investigators plan to use the OCT machine to image patient's eyes. The investigators will then use the images obtained from the OCT to objectively quantify the degree of intraocular inflammation.
Interventions
DEVICEOptical Coherence Tomography (OCT)
The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.
OTHEREye Exam
This is a brief, non-contact ocular exam.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age over 18 years old * Intervention Arm: * Active anterior chamber inflammation in at least one eye as diagnosed by clinical exam * One of the following: 1) diagnosis of uveitis OR 2) undergone cataract extraction surgery within the previous 30 days * Control Arm: * No active intraocular inflammation based on clinical exam
Exclusion criteria
* Corneal opacities in the affected eye * Anyone judged unable to understand or consent to study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Identified Inflammatory Cells on OCT Scan | Through study completion, up to 1 year. | This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cell Density Identified by OCT Scans Over Time | Baseline and up to 8 weeks. | Identification of changes in cell density in OCT scans over time |
Countries
United States
Participant flow
Recruitment details
Ophthalmology clinic, Newark, New Jersey, from 10/26/2016 to 4/1/2018
Participants by arm
| Arm | Count |
|---|---|
| Uveitis and Cataract Imaging Group Subjects will undergo up to three optical coherence tomography scans.
Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed. | 6 |
| Control Control subjects will undergo a brief, non-contact eye exam and then undergo up to three optical coherence tomography scans.
Optical Coherence Tomography (OCT): The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.
Eye Exam: This is a brief, non-contact ocular exam. | 0 |
| Total | 6 |
Baseline characteristics
| Characteristic | Total | Uveitis and Cataract Imaging Group |
|---|---|---|
| Age, Continuous | 40 years STANDARD_DEVIATION 12.5 | 40 years STANDARD_DEVIATION 12.5 |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 6 participants | 6 participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 0 |
| other Total, other adverse events | 0 / 6 | 0 / 0 |
| serious Total, serious adverse events | 0 / 6 | 0 / 0 |
Outcome results
Primary
Number of Participants With Identified Inflammatory Cells on OCT Scan
This measure pertains to the identification of cells in OCT scan of the participants. The inflammatory cells to be identified refer to white blood cells. The anterior segment OCT scan was used to attempt to identify these cells in the anterior chamber of the eyes of the participants.
Time frame: Through study completion, up to 1 year.
Population: Patients with uveitis identified from clinic.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Uveitis and Cataract Imaging Group | Number of Participants With Identified Inflammatory Cells on OCT Scan | 6 Participants |
Secondary
Change in Cell Density Identified by OCT Scans Over Time
Identification of changes in cell density in OCT scans over time
Time frame: Baseline and up to 8 weeks.
Population: 0 of 6 patients had follow up data, unable to identify change over time.